FDA 510(k)

神經歐米茄系統

K 號：K171581 · 2017-12-22

決定日期2017-12-22

產品代碼GZL

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Neuro Omega System is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K171581. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neuro Omega System?

Neuro Omega System is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K171581.

When did Neuro Omega System receive FDA 510(k) clearance?

Neuro Omega System received FDA 510(k) clearance on 2017-12-22, under 510(k) number K171581.

Who is the listed applicant for Neuro Omega System?

The FDA 510(k) record lists Alpha Omega Engineering , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neuro Omega System?

The FDA product code for Neuro Omega System is GZL.

其他以 Alpha Omega Engineering , Ltd. 為申請人之記錄

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K250601神經歐米茄系統；神經智慧系統 K220553神經歐米茄系統，神經智慧系統 K191739無菌導線確認 K172042神經導航系統，神經智慧系統

相關器械（代碼：GZL）

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官方來源

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